a study of sgn-b6a in chinese participants with advanced solid tumors

Conditions: Carcinoma, Non-Small Cell Lung; Squamous Cell Carcinoma of Head and Neck; Esophageal Squamous Cell Carcinoma; Gastric Adenocarcinoma; Esophageal Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma

Summary: this trial will look at a drug called sigvotatug vedotin (sgn-b6a) to find out whether it is safe for chinese participants who have solid tumors. it will study sigvotatug vedotin to find out what its side effects are. a side effect is anything the drug does besides treating cancer. it will also study how do chinese participants' body interact with sigvotatug vedotin.


Eligibility criteria:
inclusion criteria: * subjects must have histologically or cytologically confirmed metastatic or unresectable locally advanced solid malignancy within one of the tumor types listed below. * nsclc * hnscc * escc * gac * eac * gej adenocarcinoma * subjects must have disease that is relapsed or refractory, or be intolerant to systemic standard-of-care therapies, and in the judgement of the investigator, should have no appropriate standard-of-care therapeutic option. if a standard-of-care therapy is available that has not been administered, the reason that the therapy is not appropriate must be documented. * adequate organ function as defined by the baseline laboratory criteria obtained within 7 days prior to sgn-b6a initiation (cycle 1 day 1) * measurable or non-measurable disease per recist v1.1 at baseline. * an eastern cooperative oncology group (ecog) performance status score of 0 or 1. exclusion criteria: * history of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy. exceptions are malignancies with a negligible risk of metastasis or death. * participants with any of the following respiratory conditions: * evidence of noninfectious interstitial lung disease (ild) or pneumonitis that: * \* was previous diagnosed and required systemic steroids, or * \* is currently diagnosed and managed, or * \* is suspected on radiologic imaging at screening * known diffusing capacity of the lung for carbon monoxide (dlco) \< 50% * any grade greater than or equal to (≥) 3 pulmonary disease unrelated to underlying malignancy * prior radiation therapy to the lung that is \>30 gray (gy) within 6 months of the first dose of sigvotatug vedotin. * pre-existing peripheral neuropathy grade greater than or equal to (≥) 2 * uncontrolled diabetes mellitus * known active central nervous system metastases. participants with previously treated brain metastases may participate provided they: * are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment, * have no new or enlarging brain metastases, and * are off of corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to first dose of study drug. * known history or current diagnosis of carcinomatous meningitis * previous treatment with an mmae-containing agent or an agent targeting integrin beta-6 * prior anticancer therapies: * chemotherapy within 21 days prior to first administration of sigvotatug vedotin * targeted small molecule agents within 14 days or 5 half-lives (whichever is longer) prior to first administration of sigvotatug vedotin * antibody-based anticancer or other investigational antitumor therapy within 28 days prior to first administration of sigvotatug vedotin * focal radiotherapy or major surgery that is not completed 14 days prior to the first dose of sigvotatug vedotin * traditional or herbal medicines: * anti-cancer traditional or herbal medicines within 28 days prior to first administration of sigvotatug vedotin * traditional or herbal medicines for other purposes (such as supportive care) within 7 days prior to first administration of sigvotatug vedotin

Keywords: nscl lung neoplasm cancer of ovary ovarian cancer colorectal cancer colorectal tumors